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Dimension Vista® Flex® reagent cartridge T4

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge T4 FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Thyroxine Flex® reagent cartridge, 160 tests FDA UDI
Model / Reference
10445101 FDA UDI
Description
Thyroxine Flex® reagent cartridge, 160 tests FDA UDI

Identifiers

Catalog Number
K6065 FDA UDI
Primary DI / UDI-DI
00842768015434 FDA UDI
510(k) Number
K061655 FDA UDI
FDA Product Code
KLI FDA UDI
GMDN Term
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge T4 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K061655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI ad5c298c-2e28-400f-ba31-a507ab9ad13c 37 fields · synced May 31, 2026